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Betamethasone Acetate
C24H31FO6 434.50

Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17-dihydroxy-16-methyl-21-(acetyloxy)-, (11,16)-.
9-Fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 21-acetate [987-24-6].
» Betamethasone Acetate contains not less than 97.0 percent and not more than 103.0 percent of C24H31FO6, calculated on the anhydrous basis.
Packaging and storage— Preserve in tight containers. Store between 2 and 30.
Change to read:
B: Thin-Layer Chromatographic Identification Test 201
Test solution: 0.5 mg per mL in dehydrated alcohol.
Developing solvent system: a mixture of chloroform and diethylamine (2:1).
Procedure— Proceed as directed in the chapter. Locate the spots on the plate by lightly spraying with 10% sulfuric acid in alcoholUSP29 and heating on a hot plate or under a lamp until spots appear.
Specific rotation 781S: between +120 and +128.
Test solution: 10 mg per mL, in dioxane.
Water, Method I 921: not more than 4.0%.
Residue on ignition 281: not more than 0.2%, a platinum crucible being used.
Ordinary impurities 466
Test solution: methanol.
Standard solution: methanol.
Application volume: 10 µL.
Eluant: a mixture of toluene and isopropyl alcohol (90:10), in a nonequilibrated chamber.
Visualization: 5.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Mobile phase— Prepare a filtered and degassed mixture of water, acetonitrile, and glacial acetic acid (800:700:1.5). Make adjustments if necessary (see System Suitability under Chromatography 621).
Internal standard solution— Transfer about 35 mg of progesterone to a 50-mL volumetric flask, add Mobile phase to volume, and mix.
Standard preparation— Dissolve an accurately weighed quantity of USP Betamethasone Acetate RS in Mobile phase, and quantitatively dilute with Mobile phase to obtain a solution containing about 0.5 mg per mL. Transfer 10.0 mL of the resulting solution to a 50-mL volumetric flask, add 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix to obtain a solution having a known concentration of about 0.1 mg of USP Betamethasone Acetate RS per mL.
Assay preparation— Transfer about 50 mg of Betamethasone Acetate, accurately weighed, to a 100-mL volumetric flask, add Mobile phase to volume, and mix. Transfer 10.0 mL of the resulting solution to a 50-mL volumetric flask, add 10.0 mL of Internal standard solution, dilute with Mobile phase to volume, and mix.
Chromatographic system (see Chromatography 621)— The liquid chromatograph is equipped with a 254-nm detector and a 4-mm × 30-cm column that contains packing L1. The flow rate is about 1 mL per minute. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the relative retention times are about 3 for progesterone and 1.0 for betamethasone acetate; the resolution, R, between the analyte and internal standard peaks is not less than 2; and the relative standard deviation for replicate injections is not more than 2.0%.
Procedure— Separately inject equal volumes (about 25 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of C24H31FO6 in the portion of Betamethasone Acetate taken by the formula:
500C(RU / RS)
in which C is the concentration, in mg per mL, of USP Betamethasone Acetate RS in the Standard preparation; and RU and RS are the peak response ratios obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 267
Pharmacopeial Forum : Volume No. 31(2) Page 381
Phone Number : 1-301-816-8143